Application 090020

Type: ANDA
Sponsor: OXFORD PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GLYCOPYRROLATE	GLYCOPYRROLATE	TABLET;ORAL	1MG	No	No
002	GLYCOPYRROLATE	GLYCOPYRROLATE	TABLET;ORAL	2MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090020-001	GLYCOPYRROLATE	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA		2011-10-19
A090020-002	GLYCOPYRROLATE	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA		2011-10-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090020-001	AA
A090020-002	AA

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090020-001	GLYCOPYRROLATE	1MG	TABLET / ORAL	AA	2011-10-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090020-002	GLYCOPYRROLATE	2MG	TABLET / ORAL	AA	2011-10-19	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090020-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090020-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090020-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090020-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090020-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090020-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090020-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090020-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090020-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090020-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090020-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090020-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090020-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090020-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090020-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090020-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090020-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090020-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090020-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090020-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090020-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090020-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090020-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090020-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090020-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090020-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090020-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090020-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090020-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090020-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090020-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090020-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090020-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090020-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090020-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090020-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090020-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090020-002	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090020-001	AA	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090020-002	AA	1	`74a2ff9319b5…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 6 · 115 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	5ee5f433-fd99-4c8d-8263-b8956d489620	2024-12-12	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
glycopyrrolate	GLYCOPYRROLATE	Saptalis Pharmaceuticals, LLC.	3e6f8091-d6fe-4c8f-b897-606a70bf74bc	2024-11-12	Warnings, Adverse reactions	Name fallback brand name: glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Fresenius Kabi USA, LLC	ccafb5c2-86dd-4bb2-883a-c13e3171227c	2024-10-14	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	987ba524-361e-49c3-9e00-550a78748542	2024-10-09	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	48a8356e-377e-45ef-a1bf-e9ffec051749	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	fcb295e4-038f-4d4f-8786-4fbcd1d3c298	2024-10-04	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	33bbc475-2fe3-48ab-8a9d-56d13053593e	2024-10-04	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	Somerset Therapeutics, LLC	48cfbd5a-b133-4720-9bd7-65296064ea3c	2024-08-31	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	bfccdb26-5047-4b54-9732-ffac2d78e4d1	2024-05-29	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Fresenius Kabi USA, LLC	685aaf64-1a64-42f9-a96f-4764d650c26f	2024-05-14	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	HF Acquisition Co LLC, DBA HealthFirst	9be0ad4e-3efa-1a24-e053-2995a90a60d5	2024-02-22	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	American Regent, Inc.	62267afe-1a73-4623-984e-646db590ec5b	2024-02-07	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	HF Acquisition Co LLC, DBA HealthFirst	c4c3be3a-ea28-864f-e053-2a95a90a701a	2024-01-30	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	HF Acquisition Co LLC, DBA HealthFirst	e76bc0e4-68f5-70b4-e053-2a95a90a451e	2024-01-22	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Bryant Ranch Prepack	579d2499-6520-41fb-ae52-f3d8b9af8950	2024-01-12	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	NorthStar RxLLC	ed22456b-b488-49ec-b96b-2541f5f3c955	2024-01-10	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE	GLYCOPYRROLATE	FH2 Pharma LLC	18ca98ed-522d-470f-bb22-908bbd7d489a	2023-12-31	Warnings, Adverse reactions	Name fallback brand name: GLYCOPYRROLATE generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Medical Purchasing Solutions, LLC	0933e843-df2a-3d32-e063-6394a90a1037	2023-11-02	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE
GLYCOPYRROLATE 1ML	GLYCOPYRROLATE	XIROMED LLC	1bb2fa8a-3318-1e9a-2c79-8371bcae3d1c	2023-10-23	Warnings, Adverse reactions	Name fallback generic name: GLYCOPYRROLATE
Glycopyrrolate	GLYCOPYRROLATE	Fresenius Kabi USA, LLC	250eeef7-b1a9-45e7-a927-7807232e10be	2023-09-22	Warnings, Adverse reactions	Name fallback brand name: Glycopyrrolate generic name: GLYCOPYRROLATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.